CardioSource WorldNews | Page 76

Reversal agent available nationwide PRADAXA—the ONLY NOAC with a specific reversal agent INDICATIONS AND USAGE Pradaxa® (dabigatran etexilate mesylate) capsules is indicated: • to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation SELECT SAFETY INFORMATION BOXED WARNING: (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS Premature discontinuation of any oral anticoagulant, including PRADAXA, increases the risk of thrombotic events. If anticoagulation with PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant (B) SPINAL/EPIDURAL HEMATOMA Epidural or spinal hematomas may occur in patients treated with PRADAXA who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: • use of indwelling epidural catheters • concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants • a history of traumatic or repeated epidural or spinal punctures • a history of spinal deformity or spinal surgery • optimal timing between the administration of PRADAXA and neuraxial procedures is not known Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients who are or will be anticoagulated. CONTRAINDICATIONS PRADAXA is contraindicated in patients with: - active pathological bleeding; - known serious hypersensitivity reaction (e.g., anaphylactic reaction or anaphylactic shock) to PRADAXA; - mechanical prosthetic heart valve WARNINGS & PRECAUTIONS Increased Risk of Thrombotic Events after Premature Discontinuation Premature discontinuation of any oral anticoagulant, including PRADAXA, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. If PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant and restart PRADAXA as soon as medically appropriate. NOAC=novel oral anticoagulant. Please see additional Important Safety Information about PRADAXA on previous page and accompanying brief summary of full Prescribing Information.